Regulatory 2017-05-19T11:11:43+00:00


Key Changes in Medical Device Regulations.

Baat Medical supports partners in regulatory issues. Particular in these times this is important because of the key changes taking place in the European Union. Because of apparent weaknesses in the implementation of the Medical Devices Directive (MDD) 93/42/EEC a new Medical Devices Regulation (MDR) will be introduced in the beginning of the Year 2017. We are informing you on selected key changes, which we think, could be of importance for you.

Life-cycle approach: clinical evaluation intensified

Guidance on Authorized Representation (AR), Clinical Evaluation, Vigilance and Post-Market Clinical Follow-up has been integrated in the proposed MDR. Greater emphasis will be placed on clinical data. A Clinical Evaluation Report (CER) is imperative for all classes of devices and must be periodically updated. For implantable devices, an Expert Panel will be installed for clinical assessment.

To demonstrate Equivalence, referring to studies done with other devices, will be more challenging. One (!) Key equivalent device is allowed and clinical data for this device must be accessible. Furthermore, more clinical data must be obtained from market experience with the device. This includes active and continuous Post market surveillance with focus on safety and performance. We recommend to outlining a plan for Post market clinical follow up as early as possible.

Medical Devices: wider scope

The definition of medical devices is broadened; MDR now includes, for example, products for cleaning, sterilisation, disinfection and some medical devices that have a ‘medical character’. Selected orthopaedic implants will be upgraded to Class III, for example cardiologic devices and devices concerning the nervous system. We recommend executing a portfolio analysis to determine which products to be discontinued or to be upgraded to fulfil the new MDR requirements.

Own brand medical devices: own CE Mark certification

To bring medical devices that already have a CE mark certification to the market, but with your own branding on the label, your organization must apply now for its own certification. The process for medical devices own brand labelling certification is in many instances by document review and must be based on the original studies regarding safety and performance.

Own branding is a common practice for medical devices. Often the own brand labelling company is situated in Europe and the original manufacturer (called the OEM) situated outside Europe. The own brand labeller needs certification because, under EC directives, you become the legal manufacturer and take on all the legal responsibilities.

Unique Device Identification: imperative

Obligatory Unique Device Identification (UDI) will be introduced to allow traceability of devices through a device identifier (DI) and production series through a production identifier (PI). The identifier must also be referenced in the Declaration of Conformity.

The European Database for Medical Devices, or Eudamed, contains data on medical devices.
In the proposals for Regulations for medical devices, a completely new version of Eudamed is proposed. This ‘MDR Eudamed’ is intended to provide more data, of higher quality and with a wider accessibility.